Saturday, January 17, 2015

FDA Discusses Tumorigenicity and Oncogenicity of Vaccines, as well as Other Safety Concerns




The history of the development of vaccines is a very troubling history.  In reading up on this history, you will readily see that the FDA and drug manufacturers have a history of releasing vaccines for public use and later finding out that there were problems with those vaccines which had not been discovered or thoroughly investigated, and as a result, millions of people were exposed to risk.

Today I have been reading a document called "FDA Meeting:  Human Tumors for Vaccine Manufacture" published on November 15, 2014.  

In this document, they discuss the dangers of using cells from human tumors in making vaccines, and whether or not those cells could possibly produce tumors in those to whom the vaccine is administered.  They are using these cells to make vaccines for Influenza, HIV and Anthrax. It is alarming to me that anyone would propose such a thing.  But when you read about the history of vaccine development, they have been doing even more frightening things for years. For instance, to quote from the above manuscript,

"And so the main concerns back then, as they are today, were human adventitious agents and potential oncogenicity.  And even now some currently used vaccines are made in primary cells.  This includes influenza virus vaccines, measles, mumps and rabies vaccines.  
     In 1960, as the primary cells were being used, the virus SV40 was discovered as an adventitious agent in poliovirus vaccines.  And the vaccine was manufactured in primary rhesus monkey kidney cells, and it turned out that the SV40 could grow in those cells without producing any cytopathic effect, and so it was not recognized using the testing that was being used at the time.
     And so many received the SV40 contaminated vaccines in the late 1950's and early 1960's."

"Human adventitious agents" are viruses, bacteria, mycoplasm, fungi, rickettsia, protozoa, parasites, or TSE agents.  In other words, living organisms that are infectious.  So in the above example, the polio vaccine that was developed was incubated in rhesus monkey kidney cells, and those cells contained an infectious agent called the SV40 virus which was then passed to all those who were recipients of that vaccine.  "Primary cells" are cells that come directly from living species, rather than being created in a lab, and so primary cells are considered to have the greatest risk of containing adventitious agents that cannot be screened out. 

The same manuscript states that in the 1990's "a number of investigators reported the presence of SV40 DNA in human malignancies" although the articles goes on to state that even though several different investigators came to the same conclusion, this was not a "real" finding.  How convenient, even though the results were replicated by several different investigators, somehow this finding was not real.

"In 2010 we had a discussion with the VRBPAC (Vaccine and Related Biological Products Advisory Committee)...on porcine circovirus which was found in rotovirus vaccines.  And porcine circovirus DNA was identified in a rotovirus vaccine by the Delwart Lab in California using massively parallel sequencing techniques and other molecular studies that were consistent with the presence of PCV infectious PCV in one rotovirus vaccine, and the presence of infectious PCV was indeed confirmed."

What is a rotovirus?  Rotovirus is the most common cause of severe diarrhea among infants and children.  It attacks the cells that line the small intestine, causing gastroenteritis or "stomach flu." Worldwide, about 450,000 children die each year from rotovirus infections. 

"Another major safety concern in the use of normal cell substrates is the potential presence of latent and occult viruses, which may not be detected by currently used conventional assays."

"Tumorigenicity is defined as the ability of the intact cells to establish a tumor in an animal. A549 are known to be tumorigenic. As you can see, we confirm this in athymic nude mice. Tumorigenicity would only be an issue if intact, viable A549 cells remain in our final drug product.  We believe this is not the case for our purified, orally delivered Adenovirus vaccines."

And so you just want us to trust you on this?  Even though, historically, there have been many vaccines that have contained undetectable infectious agents which you were unable to screen out, even though you tried?  Which were touted as safe and then infected people?  You just want us to trust you when you say that it's not possible that a single intact cell which could produce tumors is present anywhere in any of these vaccines?  I personally will NOT trust anyone's word for that, given that, in the past, claims have been made for vaccines' purity and then they have been found to be contaminated. 

They have just admitted that currently used conventional screening procedures may not be able to detect all adventitious agents.  Since we are dealing with diseases which they claim are so virulent that we all need to be vaccinated against them, I certainly don't intend to willingly and knowingly allow one of these potential pathogens to be injected into me or anyone I care about.  





Copyright 2015 Judie C. McMath and The Center for Unhindered Living











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